Judge Rules FDA Mifepristone Certification Requirements Unlawful

U.S. District Judge Robert Ballou ruled on Thursday that the Food and Drug Administration unlawfully required doctors and pharmacies to be specially certified to prescribe the abortion drug mifepristone under 2023 regulations. Ballou determined that the agency failed to provide a sufficient explanation for why these restrictions were necessary, especially since the agency had previously affirmed the drug's safety and effectiveness.

The ruling resulted from a 2023 lawsuit filed by abortion providers in Kansas, Montana, and Virginia. While Ballou ordered the FDA to reconsider the rule, he did not immediately strike it down, stating he may do so when ruling on separate constitutional claims. This decision aligns with a similar finding in Hawaii.

Representatives for the plaintiffs argued the rules were not based on medicine. Amy Hagstrom Miller of Whole Woman’s Health Alliance stated the regulations serve no medical purpose, while Nancy Northup of the Center for Reproductive Rights claimed the restrictions were intended to make abortion harder to access. The FDA is currently conducting a broader safety review of mifepristone, a drug used in more than 60% of abortions in the United States.